Setting.— Five public STD clinics (Baltimore, Md; Denver, Colo; Long Beach, Calif;
Newark, NJ; and San Francisco, Calif) between July 1993 and September 1996.

Participants.— A total of 5758 heterosexual, HIV-negative patients aged 14 years or
older who came for STD examinations.

Interventions.— Arm 1 received enhanced counseling, 4 interactive theory-based sessions.
Arm 2 received brief counseling, 2 interactive risk-reduction sessions. Arms
3 and 4 each received 2 brief didactic messages typical of current care. Arms
1, 2, and 3 were actively followed up after enrollment with questionnaires
at 3, 6, 9, and 12 months and STD tests at 6 and 12 months. An intent-to-treat
analysis was used to compare interventions.

Main Outcome Measures.— Self-reported condom use and new diagnoses of STDs (gonorrhea, chlamydia,
syphilis, HIV) defined by laboratory tests.

Results.— At the 3- and 6-month follow-up visits, self-reported 100% condom use
was higher (P<.05) in both the enhanced counseling
and brief counseling arms compared with participants in the didactic messages
arm. Through the 6-month interval, 30% fewer participants had new STDs in
both the enhanced counseling (7.2%; P = .002) and
brief counseling (7.3%;P=.005) arms compared with
those in the didactic messages arm (10.4%). Through the 12-month study, 20%
fewer participants in each counseling intervention had new STDs compared with
those in the didactic messages arm (P = .008). Consistently
at each of the 5 study sites, STD incidence was lower in the counseling intervention
arms than in the didactic messages intervention arm. Reduction of STD was
similar for men and women and greater for adolescents and persons with an
STD diagnosed at enrollment.

Conclusions.— Short counseling interventions using personalized risk reduction plans
can increase condom use and prevent new STDs. Effective counseling can be
conducted even in busy public clinics.

Figures in this Article

IN THE UNITED STATES, an estimated 580000 people are infected with human
immunodeficiency virus (HIV). New acquired immunodeficiency syndrome (AIDS)
cases are declining among gay men and injection drug users but continue to
rise among heterosexuals and women.1 AIDS is
now the leading cause of death for black women aged 25 through 44 years.2 Among heterosexual patients attending publicly funded
sexually transmitted disease (STD) clinics, HIV prevalence is 50% to 100%
higher than in the general population.3

Recent therapeutic breakthroughs have led to marked improvement in morbidity
and mortality for HIV-infected persons; however, treatment costs are high
and there is still no cure.4 Sound policy recommendations
for disease prevention depend on reliable efficacy data, preferably based
on the results of well-conducted randomized controlled trials measuring disease
outcomes.5- 7 However,
there are limited data supporting the impression that current HIV prevention
strategies, including HIV/STD counseling, are effective in reducing new infections.
In the case of HIV counseling, studies that have attempted to evaluate counseling
efficacy have been limited by inadequate experimental designs, interventions,
and outcomes.5,8,9

Considerable debate has occurred on the content and duration of counseling
necessary to achieve meaningful change in risk behaviors. Many HIV counseling
programs focus on collecting risk data and providing general information about
HIV/AIDS. However, a number of health professionals have argued that, for
greatest benefit, counseling should be an interactive process aimed at personal
risk reduction.10 Brief intervention strategies
have been successfully applied in behavioral interventions for other health
risks such as alcohol use,11 but other experts
maintain that changing sex behaviors requires multiple (ie, ≥10) intervention
sessions.12

Project RESPECT was a randomized controlled trial specifically designed
to assess the efficacy of HIV prevention counseling in reducing high-risk
sexual behaviors and preventing new sexually transmitted infections. We studied
counseling approaches believed by experts to have the highest likelihood for
success and, thus, evaluated risk reduction counseling models that used an
interactive process between counselor and client. We were also concerned about
feasibility and coverage of the interventions, and thus, we studied interventions
that were acceptable to participants and able to be replicated in busy public
clinic settings. This project evaluated one-on-one HIV/STD prevention counseling
models—one with 4 sessions (200 minutes total) and the other with 2
sessions (40 minutes total). We compared the counseling models with each other
and with brief, didactic messages that approximate the one-on-one prevention
approach typically used in STD clinics and other HIV test sites.

METHODS

Study Design

The trial was conducted from July 1993 through September 1996 among
patients from public, inner-city STD clinics in Baltimore, Md; Denver, Colo;
Long Beach, Calif; Newark, NJ; and San Francisco, Calif, in collaboration
with the Centers for Disease Control and Prevention (CDC), Atlanta, Ga. Eligible
participants were HIV-negative men and women aged 14 years or older who came
to one of the clinics for a full diagnostic STD examination and agreed to
have an HIV test. Men who reported having a male sex partner in the past 12
months or who identified themselves as bisexual or homosexual were excluded
from the study. All potential participants whose command of English would
limit full participation in the interventions and those who had declined to
participate in the study at earlier clinic visits were excluded also. All
participants gave written, informed consent, and the institutional review
boards at each site reviewed and approved the protocol.

Participants were assigned randomly to 1 of 4 intervention arms (Figure 1). Those assigned to arms 1, 2, or
3 were asked to return for follow-up appointments 3, 6, 9, and 12 months after
enrollment. We included arm 4 to assess the possible intervention effects
of repeated follow-up contacts, because it was speculated that these might
be of sufficient magnitude to obscure differences between the interventions.
Arm 4 participants had no follow-up visits scheduled after the intervention
but results for syphilis and gonorrhea tests (routinely done at all 5 clinics)
were obtained each time they voluntarily returned to the clinic during the
12-month study interval. To assess the effects of repeated contact, we excluded
from the analysis STDs diagnosed for arm 3 participants at study-prompted
follow-up visits, and we compared participants in arm 3 with arm 4 on the
proportion for whom syphilis or gonorrhea was diagnosed at voluntary (unscheduled)
visits. In addition, 12 months after enrollment, arm 4 participants were sought
and, if located, interviewed. Their recent condom use was compared with arm
3 participants.

Figure 1.—Study visits were calculated
from the enrollment date to occur at 3-month intervals. The first visit occurring
during each calculated 3-month interval was considered as the follow-up visit.
For the first follow-up visit (3-month visit), the interval began 7 days before
the calculated date 3 months after enrollment and may have occurred up to
7 days before the calculated date 6 months after enrollment. HIV indicates
human immunodeficiency virus.

Randomization

Random assignment took place after enrollment and before the baseline
interviews and examinations. Allocation concealment procedures were defined
by protocol and complied with published recommendations.13
A data management company provided each site with opaque, sealed envelopes
containing computer-generated random assignments. To ensure the numbers in
arms were roughly equal, random assignments were made within blocks that varied
in size from 4 to 20 and were done separately for men and women at each site.
Once a number was assigned, it was not reassigned even if participants dropped
out of the study.

Interventions

Participants were assigned to 1 of 3 individual face-to-face HIV prevention
strategies that each involved an HIV test. All interventions encouraged consistent
condom use for vaginal and anal sex with all partners; however, interventions
were tailored to each individual's personal risks.10
For arm 1, the 4 sessions were completed within 4 weeks of enrollment. For
arms 2, 3, and 4, both sessions were completed within 10 days. Whenever possible,
the same counselor conducted all of a participant's sessions. The counselor
conducting an intervention never collected outcome data for that participant.
No interactive counseling was provided at follow-up visits; however, regardless
of assigned intervention, whenever HIV tests were obtained counselors provided
brief information about the test and answered any questions.

Patients assigned to arm 1 received enhanced counseling.10
This 4-session intervention, based on the theory of reasoned action and social
cognitive theory,14- 16
sought to change key theoretical elements (eg, self-efficacy, attitudes, and
perceived norms) underlying condom use. Session 1 lasted 20 minutes and was
conducted during the initial clinic visit; the remaining sessions were 60
minutes each. Test results for HIV were given during session 3. Each session
built on lessons from the preceding session. The first 3 sessions concluded
with a behavioral goal-setting exercise in which the participant arrived at
a small behavioral risk-reduction step that could be achieved before the next
session. At the final session, a longer-term, risk-reduction plan for each
participant was agreed on.

Participants assigned to arm 2 received brief counseling, a 2-session
intervention modeled after CDC's recommended HIV counseling for patients attending
public clinics and HIV test sites.17,18
Session 1 (20 minutes) was conducted during the initial clinic visit and was
identical to the first session of enhanced counseling. Session 2 (20 minutes)
included a discussion of the HIV test result as well as additional counseling.
The objectives of brief counseling were to assess actual and self-perceived
HIV/STD risk, to help the participant recognize barriers to risk reduction,
to negotiate an acceptable and achievable risk-reduction plan, and to support
patient-initiated behavior change. The first session concluded with a behavioral
goal-setting exercise in which the participant arrived at a small risk-reduction
step that could be achieved before the second session. At the second session,
progress in completing the behavioral step was reviewed, barriers and facilitators
to completing the behavioral step were discussed, and a longer-term risk-reduction
plan was developed.

Participants assigned to arms 3 and 4 received didactic messages. This
2-session informational intervention was designed to approximate what was
being done in most STD clinics.10 Two brief
messages about HIV and STD prevention were delivered, explicitly not engaging
the participant in interactive counseling. Session 1 (5 minutes) was conducted
by the clinician who had examined and treated the participant during the STD
clinic visit. In session 2 (5 minutes), participants were informed about their
HIV test results and limitations of the test and were given didactic prevention
messages about HIV and STD pertinent to their reported risks. Participants
were asked whether they had questions.

To ensure the quality and consistency of interventions, counselors and
clinicians received a standard training course from a single trainer, used
structured intervention protocols, and had routine observation and feedback
by on-site supervisors and an outside observer who traveled to all sites (6%
of the sessions were observed). In addition, process evaluations assessing
intervention content and client satisfaction with the interventions were performed
periodically by surveying participants, counselors, and clinicians.10

Study Outcomes

Principal outcomes were defined before the trial. Incident STDs were
defined by laboratory tests, with gonorrhea defined as a positive culture
for Neisseria gonorrhoeae or, for men, gram-negative
intracellular diplococci on a Gram stain of a urethral swab; chlamydia as
a positive Chlamydia trachomatis polymerase chain
reaction from an endocervical (women) or a urine (men) specimen; syphilis
as a suggestive history and physical examination with supportive treponemal
and nontreponemal antibody test results; and HIV infection as a repeatedly
reactive enzyme immune assay for HIV antibody with a positive confirmatory
test result. Study clinicians collected specimens necessary for each of these
tests from participants assigned to arms 1, 2, or 3, at the baseline, at 6-
and 12-month visits, and at all voluntary (unscheduled) clinic visits. Specimens
were also obtained at 3- and 9-month visits if participants or their sex partners
had symptoms of an STD or if participants requested tests. Study clinicians
used standard procedures to collect the study specimens and used an order
specified by protocol. Specimen collection procedures were periodically monitored.
Arm 4 participants returning to the clinic during a self-initiated visit underwent
only tests routinely performed at the clinics (ie, gonorrhea culture and syphilis
serology). Participants found to have STDs at the baseline or subsequent visits
were treated according to standard treatment guidelines and were advised (when
applicable) about the importance of partner treatment.19
Participants found to have HIV were referred for early intervention services,
available at all 5 clinics.

We planned to use self-reported 100% condom use during vaginal and anal
sex as principal behavioral end points. However, anal sex was rarely reported.
At enrollment, 10% of the participants reported having anal sex during the
past 3 months and half of these reported only 1 episode. Thus, we used self-reported
100% condom use during vaginal sex with all sex partners as the principal
behavioral outcome, measured as "no unprotected vaginal sex" (ie, either no
sexual contact or condom use during every sex episode). Interviewers asked
about behaviors during the preceding 3 months, including frequency of vaginal
sex and condom use with primary and any other sex partners. We calculated
condom use from the total number of times condoms were used and from the total
number of sex episodes. Interviewers also asked participants about number
of sex partners they had; about the risks of their sex partners; and about
the participants' and partners' condom use beliefs, attitudes, self-efficacy,
intentions, and perceived norms regarding consistent use of condoms. Participants
in arms 1, 2, and 3 were interviewed at enrollment, immediately after the
final intervention session, and at the 3-, 6-, 9-, and 12-month visits.

Incentives

For intervention sessions, participants were offered free condoms at
every visit and $15 for each session attended after the first session (ie,
for enhanced counseling, a maximum of $45, and for brief counseling and didactic
messages, a maximum of $15). For collection of outcome data, participants
who returned for scheduled follow-up visits were offered $15 for each questionnaire
and $25 for each STD examination. No incentives were given for voluntary (unscheduled)
STD examinations, including those completed at the 3- and 9-month visits.

Data Analysis

Assuming 15% per year cumulative incidence of STD among didactic messages
participants,20 we calculated a recruitment
goal of 6000 (1500 per arm) for 80% power to detect a 25% reduction in STDs
between counseling and control arms. For preliminary analyses of principal
outcomes, analysts were blinded to intervention arm. For all analyses, any
patient assigned a random number was included except for 75 persons whose
baseline HIV test result was positive (Figure
1). Outcome analyses were performed using data on all participants,
whether or not they completed their assigned intervention (intent to treat).20,21 For STD outcomes, we compared the
cumulative percentage of participants with any STD from enrollment until the
end of a specified visit interval. For behavioral outcomes, we compared the
proportion of subjects reporting the behavior during the 3 months before each
scheduled visit, first considering all participants who came to any follow-up
visit and then only those who came to all 4 follow-up visits (51% of all enrolled).
For comparisons between interventions, we used χ2 tests, relative
risks with 95% confidence intervals (CIs), and generalized estimating equations22 to account for correlations due to repeated observations
on the same subject. In addition to the principal outcomes, we performed 5
subset analyses, stratifying on sex, site, age (≤20 vs ≥21 years), STD
diagnosis at enrollment vs no STD, and report at enrollment of a prior HIV
test vs no prior test.

RESULTS

Participants

From July 1993 through June 1995, 13471 eligible patients were invited,
and 5833 (43%) agreed to participate. After excluding 75 patients with positive
baseline HIV test results, there were 3269 men and 2489 women (Figure 1). Study participants resembled the clinics' total populations
in that they were young (median age, 25 years), minority (59% black, 19% Hispanic,
16% white, 6% other races), and low income (54% unemployed, 42% with annual
income <$5000). Study participants and those who had refused were similar
in age, racial and ethnic background, and education (median, 12 years). But
compared with those who had refused, participants were more likely to be women
(relative risk [RR], 1.49; 95% CI, 1.44-1.55), to have had an STD at enrollment
(RR, 1.19; 95% CI, 1.14-1.24), and to have been previously tested for HIV
(RR, 1.13; 95% CI, 1.08-1.18). The intervention arms were similar at baseline
with respect to demographic characteristics, risk behaviors, condom use, and
STD diagnoses at enrollment (Table 1).

Intervention Adherence

Of 5758 patients enrolled, 82% completed all assigned intervention sessions.
Completion was lower (P<.001) for those in the
4-session enhanced counseling arm (72%) than for those in either of the 2-session
interventions (brief counseling, 85%; didactic messages, 85%). For the enhanced
counseling arm, 99% of participants completed the first session, 80% completed
the second session, 72% completed the third session, and 72% completed all
4 sessions. Regardless of assignment, most participants (>85%) surveyed about
the interventions reported that the sessions were "informative," "good," and
"helpful."

Coverage at Follow-up Visits

Of the 4328 participants assigned to follow-up visits every 3 months,
71% returned for the 3-month, 70% for the 6-month, 64% for the 9-month, and
66% for the 12-month visits. Of all 4328 participants, 81% returned for at
least 1 of the 4 follow-up visits; 73% for at least 2 visits; 63% for 3 visits;
and 51% for all 4 scheduled visits. Return for follow-up visits did not differ
significantly between intervention arms.

Intervention Efficacy Behaviors

At the follow-up visits, reported condom use and "no unprotected vaginal
sex" increased substantially over baseline for all 3 interventions (Figure 2). At the 3- and 6-month visits the
greatest increases were among those in the 2 counseling intervention arms,
with enhanced counseling participants most frequently reporting any condom
use (86%) and "no unprotected vaginal sex" (46%). At the 3-month visit, enhanced
counseling participants reported "no unprotected vaginal sex" significantly
more often than participants in the didactic messages control intervention
arm (46% vs 38%; RR, 1.21; 95% CI, 1.09-1.35). This was also true for brief
counseling participants vs didactic messages participants (44% vs 38%; RR,
1.15; 95% CI, 1.03-1.27). Differences in "no unprotected vaginal sex" between
enhanced counseling and brief counseling were small (46% vs 44%; RR, 1.06;
95% CI, 0.96-1.17). Frequency of sex was similar among the interventions.
At the 6-month visit, differences in "no unprotected vaginal sex" between
interventions were less pronounced, although trends were similar (39% enhanced
counseling vs 34% didactic messages; RR, 1.14; 95% CI, 1.01-1.28; and 39%
brief counseling vs 34% didactic messages; RR, 1.12; 95% CI, 1.00-1.25). At
the 9- and 12-month visits, any condom use and "no unprotected vaginal sex"
were reported more frequently than at enrollment, but there were no significant
differences among interventions. Considering only the 2732 participants who
came to all 4 follow-up visits, we observed similar results. Using generalized
estimating equations, we found enhanced counseling participants were more
likely to report "no unprotected sex" than participants in the other interventions
at 12 months (P = .02).

Figure 2.—Percentage of participants
reporting condom use with vaginal sex during the preceding 3 months, baseline,
and 3-, 6-, 9-, and 12-month visits.

The interventions focused on consistent condom use, but we observed
modest differences among them for some other "safe" behaviors (Table 2). At the 3- and 6-month visits, more participants in each
counseling intervention reported safe behaviors compared with those in the
didactic messages arm. For measures of condom use (eg, "any use" and "condoms
with last sex"), enhanced counseling participants tended to report safe behaviors
most often, followed by those who were assigned to the brief counseling arm
and then those who were assigned to the didactic messages arm. But for safe
behaviors unrelated to condoms (eg, "no casual partners" and "no new partners"),
brief counseling participants tended to report safe behaviors most often,
followed by those assigned to the enhanced counseling arm, and then by those
assigned to the didactic messages arm. At the 9- and 12-month visits, there
were no significant differences between the interventions.

Table Graphic Jump LocationTable 2.—Proportion of Participants
With Selected Safe Behaviors by Intervention Arm at the 3-Month and 6-Month
Visits*

Sexually Transmitted Diseases

Through the 12-month visit, a total of 549 participants (12.7%) were
diagnosed as having a new STD, including 314 men (12.8%) and 235 women (12.6%).
There were 271 participants (6.3%) diagnosed as having gonorrhea; 315 (7.3%)
as having chlamydia; 25 (0.6%) as having syphilis; and 8 (0.2%) as having
HIV. Some participants had multiple diagnoses.

Fewer participants assigned to either of the interactive counseling
intervention arms developed new STDs compared with participants assigned to
the didactic messages control arm (Figure
3). Through the 6-month visit, 149 participants (10.4%) in the didactic
messages arm had new STDs compared with 103 (7.2%) in the enhanced counseling
arm (RR, 0.69; 95% CI, 0.54-0.88) and 107 (7.3%) in the brief counseling arm
(RR, 0.71; 95% CI, 0.58-0.89). Through the 12-month visit, 211 participants
(14.6%) in the didactic messages arm had developed new STDs, compared with
165 (11.5%) in the enhanced counseling arm (RR, 0.78; 95% CI, 0.64-0.94) and
173 (12.0%) in the brief counseling arm (RR, 0.81; 95% CI, 0.67-0.98). The
2 interactive counseling interventions had very similar cumulative incidence
of STD through the 6- and 12-month visits. The number of participants counseled
per STD averted during the 12-month study interval was 31 for the enhanced
counseling arm and 38 for the brief counseling arm.

Figure 3.—Percentage of participants
with a new sexually transmitted disease through the 3-,6-, 9-, and 12-month
visits.

The STD reduction associated with the interactive counseling interventions
was similar among men and women, that is, about 30% fewer participants had
new STDs at the 6-month visit and 20% fewer participants had new STDs at the
12-month visit, respectively. Consistently at all 5 study sites fewer participants
in the counseling intervention arms had new STDs compared with those in the
didactic messages arm. Considering specific STDs as outcomes, counseling was
equally effective for gonorrhea and chlamydia. For HIV, there were 4 new infections
among those in the didactic messages arm, 4 in those assigned to the enhanced
counseling arm, and none in those assigned to the brief counseling arm (P=.06) through the 12-month visit. In the subgroup analyses,
efficacy was highest in the subgroups with highest risk (ie, highest STD incidence),
although differences were not significant at P<.05.
The relative effectiveness of counseling was greatest for patients aged 20
years or younger (vs those older), patients reporting no prior HIV test (vs
those reporting a test), and patients who had an STD diagnosed at the enrollment
visit (vs those with no STD).

Effect of Repeated Contact

Gonorrhea and syphilis were diagnosed at voluntary clinic visits less
often among arm 3 participants (3.3%) than arm 4 participants (4.1%), although
observed differences may have been due to chance (RR, 0.80; 95% CI, 0.55-1.17).
At 12 months, only 462 arm 4 participants (32%) were found and interviewed.
However, compared with these, arm 3 participants were more likely to report
"no episodes of unprotected vaginal sex" during the previous 3 months (39%
vs 34%; RR, 1.15; 95% CI, 0.99-1.33). Although some biases are possible, these
analyses were consistent in suggesting that repeated contact with study personnel,
instruments, or both may have themselves had a modest intervention effect.

COMMENT

Project RESPECT demonstrated that interactive, client-centered HIV/STD
counseling resulted in an overall reduction in STD incidence of about 30%
after 6 months and 20% after 12 months of follow-up. The STD reduction occurred
among both men and women and was observed consistently at all 5 study sites.
Since 1994, CDC has recommended client-centered HIV prevention counseling
for persons determined to be at risk for HIV infection.17,18
Several observational studies and a few randomized trials using behavioral
outcomes support that direct, personalized ("client-centered") counseling
is likely to initiate the behavior changes that might lead to reduction in
new HIV infections.8,9,23,24
However, the efficacy of such counseling in reducing HIV or other STDs had
not been shown. This large randomized controlled trial evaluating interactive
risk reduction counseling among STD clinic patients is the first to report
that counseling leads to reduction in sexually transmitted infections. In
addition to concerns about efficacy, concerns that interactive counseling
is not feasible for busy, publicly funded clinics, or cannot be conducted
by the personnel currently employed by health departments, should now be put
to rest.

The follow-up results indicate that interactive counseling had greatest
disease reduction benefit during the first 6 months after intervention completion
but suggest that some counseling benefits continued over time. Even if the
counseling benefits wane, a 20% STD reduction over 12 months is important
for several reasons. A 20% STD reduction in these clinic patients will diminish
disease prevalence in the community. In addition, reducing or eliminating
STDs such as syphilis, gonorrhea, chlamydia, and herpes may directly reduce
new HIV infections, as the presence of these STDs has been found to enhance
HIV acquisition and transmission.7,25
Furthermore, even transient reduction in risk for an individual may have large
effects on lifetime risk if the behavior changes occur when the likelihood
of infection is high (eg, during adolescence). As for whether the STD reduction
found with counseling would hold true for HIV as well, we cannot say this
with certainty. To the extent that sexual transmission of the condom-preventable
STDs we studied here and HIV are similar, client-centered counseling is likely
to have the same disease prevention benefits. Human immunodeficiency virus
seroconversion is relatively rare in the United States, even among this high-risk
population. To find a 20% reduction in HIV transmission in this population
with incidence of 0.3% per year would require a study size of 241000 in order
to have an 80% likelihood of detecting a difference. The cost of such a study
would be prohibitive. But the cost of counseling programs for 241000 people
(which we estimate at $8 per patient over current costs) would be easily recovered
in savings from preventing an expected 145 new AIDS cases, which cost an estimated
$100000 to $200000 per case.4

The finding that the 4-session enhanced counseling and the much shorter
2-session brief counseling had equivalent STD reduction was surprising and
is good news for public health programs. Conventional wisdom has suggested
that multiple-session interventions are needed for effective change of sexual
behavior,12 but our results challenge this
viewpoint. Timing may be an important element for intervention success; it
is possible that individuals who seek STD testing and treatment are particularly
amenable to behavior change. However, this is not the first study indicating
that brief interventions may be as effective as longer therapies. Recently
published results of a large alcohol treatment study indicate that a brief
motivational intervention was as effective in achieving alcohol cessation
as a longer, more intensive counseling intervention.11
A brief intervention in active drug users has also been reported as being
effective as a longer intervention in changing risk behaviors.26
We studied 4-session counseling because we were not convinced that CDC's recommended
2-session counseling would have such a powerful disease reduction impact.
Although long recommended and supported by counselors, client-centered HIV
prevention counseling is seldom done in STD clinics, probably because program
managers also have not believed that a 2-session intervention could have a
significant impact. However, this brief counseling model was designed for
implementation, at low cost and with existing personnel, in the context of
routine health care services. The intervention adherence we found suggests
that 2-session counseling would have at least the same retention as the didactic
approach that is currently used and would have greater retention than longer
therapies.

This study has several strengths. The randomized controlled design,
if well conducted, permits the most unbiased comparison of effects. In conducting
this trial, we sought to comply with recommended procedures that have since
been published as guidelines for conducting and reporting randomized controlled
trials.27 The use of disease as an outcome
measure can help validate self-reported data. More important, measuring disease
outcomes allowed us to measure directly the interventions' disease reduction
effects, and thus permit counseling to be directly compared with other HIV/STD
prevention strategies. Losses to follow-up could be an important source of
bias if those not returning differed in risk from those who returned for follow-up.
Our 66% follow-up after 12 months (81% with at least 1 follow-up visit) is
within an acceptable range for prospective studies. Follow-up was similar
for all intervention arms, and our study population rarely sought STD care
at other locations,28 so the differences between
interventions are unlikely to be caused by loss to follow-up. We also attempted
to minimize biases in the analysis by identifying principal outcomes before
the trial and by masking investigators to intervention strategies during preliminary
analyses. An additional strength of this study was the use of several quality-control
procedures, helping ensure that the counseling interventions were conducted
by counselors at all sites consistently and as conceived.10
Also, the long follow-up period allowed us to measure the interventions' effects
over time.

We were unable to avoid some potential biases. One limitation mentioned
earlier was the use of STDs as a surrogate for HIV infection. Although STDs
inform about unprotected sex and partner risk, they may not be an accurate
measure of heterosexual HIV risk.29 Generalizability
of results is also of concern. We studied 5 widely located STD clinics that
we believe to be fairly representative of the range of public clinics in the
United States. However, the 43% enrollment rate was low (although not unexpected,
given the length and intensity of the follow-up that participants were asked
to complete). Intervention enrollment may be higher in practice because participants
would not need to return for the study-related follow-up. However, participation
may be lower without the $15 incentive used in this study. Perhaps more important,
results may not pertain to other populations or settings. Since we studied
only heterosexual STD clinic patients, we cannot know whether similar counseling
sessions would be effective in other settings where HIV tests are performed,
such as alternative test sites (where many gay men go for testing), among
injection drug users, or at managed care plans (where many adolescents and
young women receiving Medicare obtain health care). However, the individually
tailored approach used in the counseling models studied here could be easily
adapted to different settings.

We conclude that brief, interactive HIV/STD prevention counseling prevents
new STDs and, by inference, HIV infections. This quality of counseling can
be successfully conducted in busy public clinic settings. These results have
several implications for existing programs, particularly those serving populations
with a high HIV/STD prevalence. First, most clinics already employ HIV counselors
who collect risk data, discuss the HIV test, and provide didactic prevention
messages.30 These counselors could prevent
new infections if they adopted interactive HIV/STD prevention counseling aimed
at risk reduction. The Project RESPECT counselors were health department staff
members who were motivated and enthusiastic but typically did not have advanced
degrees or long experience in interactive counseling. Second, quality-control
measures are critical to intervention success and are feasible for most programs.10 Quality assurance should be approached as an integral
part of the process and as a means of providing a better product. Third, some
programs might consider targeting counseling to higher-risk clients, such
as adolescents and individuals with previous STDs, to reduce costs while retaining
large effects on disease reduction. Finally, given our finding that counseling
benefits may wane over time, we wonder if an additional interactive counseling
session done some months after brief 2-session counseling might be beneficial
and might sustain or even enhance the risk-reduction benefits observed in
this trial.

Centers for Disease Control and Prevention. HIV Counseling, Testing, and Referral Standards and Guidelines. Atlanta, Ga: US Dept of Health and Human Services, Centers for Disease
Control and Prevention; 1994.

Centers for Disease Control and Prevention. HIV Counseling and Testing in Publicly Funded Sites: 1995 Summary
Report . Atlanta, Ga: US Dept of Health and Human Services, Centers for Disease
Control and Prevention; September 1997.

Figures

Figure 1.—Study visits were calculated
from the enrollment date to occur at 3-month intervals. The first visit occurring
during each calculated 3-month interval was considered as the follow-up visit.
For the first follow-up visit (3-month visit), the interval began 7 days before
the calculated date 3 months after enrollment and may have occurred up to
7 days before the calculated date 6 months after enrollment. HIV indicates
human immunodeficiency virus.

Centers for Disease Control and Prevention. HIV Counseling, Testing, and Referral Standards and Guidelines. Atlanta, Ga: US Dept of Health and Human Services, Centers for Disease
Control and Prevention; 1994.

Centers for Disease Control and Prevention. HIV Counseling and Testing in Publicly Funded Sites: 1995 Summary
Report . Atlanta, Ga: US Dept of Health and Human Services, Centers for Disease
Control and Prevention; September 1997.

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